Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001091695p
Ethics application status
Submitted, not yet approved
Date submitted
10/08/2023
Date registered
17/10/2023
Date last updated
17/10/2023
Date data sharing statement initially provided
17/10/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
A Randomised Controlled Trial of Subacromial Local Anaesthetic Delivery Following Rotator Cuff Surgery (SALAD Trial)
Scientific title
A Randomised Controlled Trial Evaluating the Efficacy of Post-Operative Pain Relief Using Subacromial Local Anaesthetic Delivery Following Rotator Cuff Surgery (SALAD Trial)
Secondary ID [1] 310346 0
None
Universal Trial Number (UTN)
Trial acronym
SALAD Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rotator Cuff Repair 331080 0
Condition category
Condition code
Anaesthesiology 327868 327868 0 0
Pain management
Musculoskeletal 327869 327869 0 0
Other muscular and skeletal disorders
Surgery 327870 327870 0 0
Other surgery
Injuries and Accidents 328395 328395 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention being assessed in this trial is a Programmed Intermittent Bolus of Local Anaesthetic into the subacromial space via a subacromial catheter following primary arthroscopic rotator cuff repair procedures.
The anaesthetic to be delivered through the subacromial catheter is a 200mL bag containing 0.2% ropivacaine with 12ml solution administered as a second hourly bolus. The first dose of local anaesthetic or placebo is administered in the Post Anaesthesia Care Unit (PACU) as the pump is connected to the patient. The Portex 16g epidural catheter is typically removed on day 1 post-operatively prior to patient discharge; the catheter will not be retained longer than is required for standard post-operative analgesia purposes.
The standard post-operative analgesia protocol will be instituted with Fentanyl or Oxycodone Patient Controlled Anesthesia (PCA) on the ward to continue as required. Under normal circumstances, the PCA would be taken down at the Acute Pain Service (APS) visit on day 1. Most patients will be able to go home on day 1 post-operatively and will not require a PCA beyond the first 24 hours.
The electronic medical record and anaesthetic administration record will be used to monitor adherence to the intervention and collect the primary outcome of milligrams of morphine or equivalent (MeQ).
Intervention code [1] 326745 0
Treatment: Surgery
Intervention code [2] 326746 0
Treatment: Drugs
Comparator / control treatment
The control treatment is the administration of a placebo infusion (saline) into the subacromial space via a subacromial catheter following primary arthroscopic rotator cuff repair procedures.
Control group
Placebo

Outcomes
Primary outcome [1] 335716 0
Post operative dose of morphine or equivalent in milligrams of morphine or equivalent (MEQ) to be collected via medical record review
Timepoint [1] 335716 0
Within the first 24 hours postoperatively
Secondary outcome [1] 425282 0
Post Operative Pain Score (0 – 10) to be collected via medical record review
Timepoint [1] 425282 0
Measured at least 2 hourly for the first 24 hours postoperatively
Secondary outcome [2] 425283 0
Post-operative patient non-opioid analgesic use to be collected via medical record review
Timepoint [2] 425283 0
Within the first 24 hours postoperatively
Secondary outcome [3] 425284 0
Brief Pain Inventory (BPI) to be collected via a patient reported outcomes survey designed for this study which will be administered preoperatively and at one week postoperative
Timepoint [3] 425284 0
Preoperatively and one week postoperatively
Secondary outcome [4] 425285 0
90 day complication rate to be collected through review of medical records and patient reported complications via a patient reported outcomes survey designed for this study
Timepoint [4] 425285 0
90 days postoperatively
Secondary outcome [5] 425286 0
90 day readmission rate to be collected through review of medical records and patient reported readmissions via a patient reported outcomes survey designed for this study
Timepoint [5] 425286 0
90 days postoperatively

Eligibility
Key inclusion criteria
Patients undergoing primary unilateral shoulder surgery for rotator cuff repair with or without adjunct bony procedures (subacromial decompression, distal clavicle excision)
Patients aged greater than or equal to 18 years of age
American Society of Anesthesiologists (ASA) physical status I to III
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Undergoing revision surgery
Contraindication to local anaesthetic administration
Co-existent coagulopathy
Chronic opioid use
Cognitive impairment such that a patient is unable to independently consent to participate

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
An independent Research Officer will be responsible for generating the randomisation schedule and managing the master file which will contain the sequential randomisation allocations, to ensure the randomisation schedule is followed. This trial will implement a sealed envelope randomisation system, with allocations concealed in opaque sequentially numbered envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be allocated 1:1 to local anaesthesia or placebo (saline) infusion. Group assignment will be carried out centrally and randomly determined by a computer generated code in blocks of 2 and 4.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis
Clinically relevant baseline variables will be tabulated and compared between groups. For demographic data, categorical variables will be compared between groups using the chi-squared test (frequencies and proportions). Continuous variables will be compared using the t-test (means) or Wilcoxon 2-sample test (median). For all other data, linear regression models will be used to calculate between-group mean differences (MD) and 95% confidence intervals (CI) for continuous variables. Logistic regression models will be used to calculate between-group differences (expressed as odds ratios, OR, and 95% CI) for the categorical variables. Spearman’s rank correlation co-efficient will be calculated for non-parametric data.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/11/2023
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
96
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 25353 0
Royal Prince Alfred Hospital - Camperdown
Recruitment postcode(s) [1] 41082 0
2050 - Camperdown

Funding & Sponsors
Funding source category [1] 314552 0
Hospital
Name [1] 314552 0
Department of Orthopaedic Surgery, Royal Prince Alfred Hospital
Country [1] 314552 0
Australia
Funding source category [2] 314553 0
Other Collaborative groups
Name [2] 314553 0
Surgical Outcomes Research Centre (SOuRCe)
Country [2] 314553 0
Australia
Primary sponsor type
Government body
Name
Sydney Local Health District
Address
Royal Prince Alfred Hospital, 50 Missenden Rd, Camperdown NSW 2050, Australia
Country
Australia
Secondary sponsor category [1] 316509 0
None
Name [1] 316509 0
Address [1] 316509 0
Country [1] 316509 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 313590 0
Sydney Local Health District Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 313590 0
Ethics committee country [1] 313590 0
Australia
Date submitted for ethics approval [1] 313590 0
13/09/2023
Approval date [1] 313590 0
Ethics approval number [1] 313590 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 128666 0
Dr Jeffrey Petchell
Address 128666 0
Royal Prince Alfred Hospital, 50 Missenden Rd, Camperdown NSW 2050
Country 128666 0
Australia
Phone 128666 0
+61 02 9515 7508
Fax 128666 0
Email 128666 0
[email protected]
Contact person for public queries
Name 128667 0
Kate Alexander
Address 128667 0
Level 9, Building 89, Royal Prince Alfred Hospital, 50 Missenden Road, Camperdown, NSW 2050
Country 128667 0
Australia
Phone 128667 0
+61 02 9515 1977
Fax 128667 0
Email 128667 0
[email protected]
Contact person for scientific queries
Name 128668 0
Kate Alexander
Address 128668 0
Level 9, Building 89, Royal Prince Alfred Hospital, 50 Missenden Road, Camperdown, NSW 2050
Country 128668 0
Australia
Phone 128668 0
+61 02 9515 1977
Fax 128668 0
Email 128668 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
At this point in time, the IPD will not be shared. This may change during the trial's recruitment/ analysis stage.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.